Phase I Study of Allogeneic Transforming Growth Factor-beta Receptor Type 2 Knockout CD70 CAR NK Cells in Treatment Refractory Clear Cell Renal Cell Carcinoma
M.D. Anderson Cancer Center
Summary
Testing an investigational cancer therapy called TGFBR-2 KO CD70 CAR NK cell therapy.
Description
Primary Objective • To determine the safety, tolerability, maximum tolerated dose (MTD), and optimal celldose (OCD) of chimeric antigen receptor TGFBR-2 KO CD70 CAR NK cells in participants with advanced ccRCC. Secondary Objectives • To determine the antitumor activity of TGFBR-2 KO CD70 CAR NK cells. Although the clinical benefit of TGFBR-2 KO CD70 CAR NK cells has not yet been established in ccRCC, the intent of offering this treatment is to provide a possible therapeutic benefit and thus, the participants will be carefully monitored for tumor response and symptom relief in addition to saf…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria * Participants must have histologically confirmed ccRCC that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. * Confirmation of CD70 expression ≥ 10% by immunohistochemistry staining of the participants primary renal tumor or a metastatic lesion biopsy specimen will be required for enrollment in the study. * Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for nonnodal lesions and s…
Interventions
- DrugLymphodepleting chemotherapy
Given by IV
- DrugDexamethasone
Given PO
- DrugFludarabine
Given by IV
- DrugCyclophosphamate
Given by IV
- DrugTGFBR-2 KO CD70 CAR NK
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas